Evaluation of Return to Work Rehabilitation

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01926574
Collaborator
St. Olavs Hospital (Other)
300
2
4
108
150
1.4

Study Details

Study Description

Brief Summary

Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. Hence, the need for documented effective vocational rehabilitation programs is pressing. Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal-, unspecific- and common mental disorders. Aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW rehabilitation programs.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: long rehabilitation program
  • Behavioral: short rehabilitation program
  • Behavioral: Acceptance and commitment therapy (ACT)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Evaluation of Inpatient-return- To-work, Multicomponent, Rehabilitation Programs for Persons Temporary Out of Work With Musculoskeletal-, Unspecific-, and/or Common Mental Health Disorders; Randomized Controlled Trial
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jun 1, 2015
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: long rehabilitation

a 3.5-week, in-patient rehabilitation program, organized as a 7-hour workday with weekends off, simulating a close to normal summer work-week in Norway, and mainly group-based with maximum 8 participants per group. Focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving.

Behavioral: long rehabilitation program

Experimental: short rehabilitation

4+4 full days of rehabilitation at Hysnes Rehabilitation Center, separated by 2 weeks living at home. Group-based with 8 participants per group, focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving. A workplace visit will be included in addition to the 4 + 4 rehabilitation days, if considered relevant.

Behavioral: short rehabilitation program

Active Comparator: Acceptance and commitment therapy

6 dynamic processes (committed action, self-as-context, presence in the moment, values, defusion and acceptance) are targeted both in group-sessions and individual meetings. Only the psychological part of the experimental interventions is applied, in an outpatient setting.

Behavioral: Acceptance and commitment therapy (ACT)

No Intervention: Untouched

this group will be followed in registers at group level and not be aware of their participation in the study

Outcome Measures

Primary Outcome Measures

  1. time until full sustainable return-to-work (RTW) [1 year]

    return-to-work i.e. for at least 4 weeks without relapse

  2. Total number of sickness absence days [1 year]

    after enrollment in the study (i.e. after pre-screening)

Secondary Outcome Measures

  1. Sickness absence days [3 years]

  2. sickness absence days [5 years]

  3. Health related quality of life [1 year]

  4. Subjective health complaints [1 year]

    Pain, depression, anxiety, and other subjective complaints

  5. Physical activity [1 year]

  6. physical, social and emotional functional status [1 year]

  7. Psychological and social factors at work [1 year]

  8. readiness for return to work [1 year]

  9. fear avoidance beliefs [1 year]

  10. psychological flexibility and acceptance [1 year]

  11. share of workers at work [1 year]

Other Outcome Measures

  1. Health economics from the societal perspective [1 year]

    Cost-effectiveness, cost-utility and cost-benefit methods.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • living in the counties of Trøndelag

  • on sick leave 2-12 months

  • current sick leave status of 50% - 100%

  • ICPC-2 (International Classification of Primary Care, Second edition) diagnosis within the L (musculoskeletal), P (psychiatric) or A (unspecific disorders) categories

Exclusion Criteria:
  • alcohol or drug abuse

  • serious somatic or psychological disorders

  • a specific disorder requiring specialized treatment

  • pregnancy

  • currently participating in another treatment program

  • insufficient Norwegian speaking or writing skills to participate in group session and fill out questionnaires

  • scheduled for surgery within the next 6 months

  • serious problems with functioning in a group setting

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hysnes Rehabilitation Centre Rissa Norway
2 St. Olavs University Hospital Trondheim Norway

Sponsors and Collaborators

  • Norwegian University of Science and Technology
  • St. Olavs Hospital

Investigators

  • Study Director: Roar Johnsen, phd prof, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01926574
Other Study ID Numbers:
  • 2012/1241-1
First Posted:
Aug 21, 2013
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Norwegian University of Science and Technology

Study Results

No Results Posted as of Apr 8, 2021